| Condition or disease | Intervention/treatment |
|---|---|
| Aging Disorder Age Problem Healthy Aging Immunity Disorders Frailty Syndrome Behaviors, Health Health Care Utilization | Other: medical history, blood and urine tests |
One of the goals is assessing the prevalence and control of age-related diseases and of the "geriatric giants" (immobility, instability, incontinence, sensory deficiency, cognition and mood disorders) which lead to frailty, disability and dependence. Monitoring of health status, health behaviors and identifying socio-economic factors favoring successful aging will be significant. As the polypragmasy and adverse drug reactions remain a significant issue in the geriatric care, pharmacotherapy and medical adherence will also be examined.
The additional purpose of the study is to evaluate the utilization and access to health care and social services in respect to needs for assistance and long-term care, as well as the level and different forms of these needs.
The project is planned as a cross-sectional survey of representative sample of 6000 people aged 60 years and over. The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, anthropometric and blood pressure measurements and laboratory tests. The data are collected by well-trained nurses during three visits at respondents homes.
| Study Type : | Observational |
| Estimated Enrollment : | 6000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey. |
| Actual Study Start Date : | January 1, 2018 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
60 - 65 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
|
65 - 69 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
|
70 - 74 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
|
75 - 79 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
|
80 - 84 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
|
85 - 89 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
|
≥90 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
|
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The research population is assumed to include 6000 individuals in seven equivalent age cohorts (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-84 years, 85-89 years, 90+ years old) with equal representation of males and females in each of them.
Research participants were randomly recruited in a stratified, proportional draw. The pattern for respondent selection was designed to obtain a population representative for Polish old citizens.
Inclusion Criteria:
Exclusion Criteria:
| Contact: Tomasz R. Zdrojewski, MD, Prof | +48 58 3491975 | tz@gumed.edu.pl | |
| Contact: Lukasz Wierucki, MD, PhD | +48583491975 | wierucki@gumed.edu.pl |
| Poland | |
| Medical University of Gdańsk | Recruiting |
| Gdańsk, Poland | |
| Contact: Tomasz R. Zdrojewski, MD, Prof +48 58 3491975 tz@gumed.edu.pl | |
| Contact: Lukasz Wierucki, MD, PhD +48 58 3491975 wierucki@gumed.edu.pl | |
| Principal Investigator: | Tomasz R. Zdrojewski, MD, Prof | Medical University of Gdansk, Poland |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 15, 2019 | ||||||||
| First Posted Date | July 19, 2019 | ||||||||
| Last Update Posted Date | July 19, 2019 | ||||||||
| Actual Study Start Date | January 1, 2018 | ||||||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey. | ||||||||
| Official Title | Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey. | ||||||||
| Brief Summary | The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland. | ||||||||
| Detailed Description |
One of the goals is assessing the prevalence and control of age-related diseases and of the "geriatric giants" (immobility, instability, incontinence, sensory deficiency, cognition and mood disorders) which lead to frailty, disability and dependence. Monitoring of health status, health behaviors and identifying socio-economic factors favoring successful aging will be significant. As the polypragmasy and adverse drug reactions remain a significant issue in the geriatric care, pharmacotherapy and medical adherence will also be examined. The additional purpose of the study is to evaluate the utilization and access to health care and social services in respect to needs for assistance and long-term care, as well as the level and different forms of these needs. The project is planned as a cross-sectional survey of representative sample of 6000 people aged 60 years and over. The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, anthropometric and blood pressure measurements and laboratory tests. The data are collected by well-trained nurses during three visits at respondents homes. |
||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
36 ml of whole blood and 20 ml of urine samples
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population |
The research population is assumed to include 6000 individuals in seven equivalent age cohorts (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-84 years, 85-89 years, 90+ years old) with equal representation of males and females in each of them. Research participants were randomly recruited in a stratified, proportional draw. The pattern for respondent selection was designed to obtain a population representative for Polish old citizens. |
||||||||
| Condition |
|
||||||||
| Intervention | Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
6000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2020 | ||||||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 60 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
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| Listed Location Countries | Poland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04026815 | ||||||||
| Other Study ID Numbers | 6/5/4.2/NPZ/2017/1203/1257 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Tomasz Zdrojewski, Medical University of Gdansk | ||||||||
| Study Sponsor | Medical University of Gdansk | ||||||||
| Collaborators |
|
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| Investigators |
|
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| PRS Account | Medical University of Gdansk | ||||||||
| Verification Date | July 2019 | ||||||||